Lower extremity bypass vs endovascular therapy for young patients with symptomatic peripheral arterial disease

TRANS-ATLANTIC DEBATE Thomas L. Forbes, MD, and Jean-Baptiste Ricco, MD, PhD, Section Editors

Lower extremity bypass vs endovascular therapy for young patients with symptomatic peripheral arterial disease Mauri J. A. Lepäntalo, MD,a Rabih Houbballah, MD,b Maxime Raux, MDb and Glenn LaMuraglia, MD,b Helsinki, Finland; and Boston, Mass The uncertainty continues over the best approach to patients with symptomatic peripheral arterial disease. Medical therapy and risk factor modification is part of any treatment regimen; with this there is little disagreement. However, with the introduction of lesser invasive percutaneous technologies, the discussion regarding surgical and endovascular therapies has become more and more complicated. Unfortunately, there is a relative shortage of robust outcomes data to support many of our specific treatment recommendations. Younger patients are an especially troublesome patient cohort. They have consistently shown poorer outcomes after any intervention compared with older patients and may represent a subset of more aggressive atherosclerotic disease. Our debaters will discuss their preferred approaches to these difficult patients in the context of the currently available supporting literature. ( J Vasc Surg 2012;56:545-55.)

PART I: LOWER EXTREMITY BYPASS IS THE PREFERRED TREATMENT FOR PATIENTS AGED <65 YEARS OLD WITH SYMPTOMATIC INFRAINGUINAL ARTERIAL DISEASE Mauri J. A. Lepäntalo, MD, Helsinki, Finland Age is an issue. Younger patients have longer life expectancy and thus need more durable treatment solutions. Of 1725 consecutive infrainguinal revascularizations for symptomatic peripheral arterial disease (PAD) in Helsinki University Central Hospital, as many as 482 patients (28%) belonged to this group of patients aged ⬍65 years. Most of revascularized legs had critical limb ischemia (CLI): among From the Department of Vascular Surgery, Helsinki University Central Hospital, Helsinkia; and the Division of Vascular & Endovascular Surgery of the General Surgical Services, Massachusetts General Hospital and Harvard Medical School, Boston.b Dr LaMuraglia was supported, in part, by grants from the Monte and Rita Goldman Fund and John F. Murphy and the Bay State Federal Savings Foundation. Author conflict of interest: none. This article is being copublished in the Journal of Vascular Surgery® and the European Journal of Vascular and Endovascular Surgery®. Reprint requests: Dr Mauri J. A. Lepäntalo, Department of Vascular Surgery, Helsinki University Central Hospital, POB 40, 00029 HUS, Finland (e-mail: [email protected]); and Dr Glenn LaMuraglia, Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, MA 02114 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214/$36.00 Copyright © 2012 by the Society for Vascular Surgery. http://dx.doi.org/10.1016/j.jvs.2012.06.053

this patient cohort the 5-year survival of patients ⬍65 years old was 60%, whereas it was 48% in older patients. Intermittent claudication. Intermittent claudication caused by infrainguinal arterial disease can mostly be treated conservatively. Yet, when functional capacity is threatened, claudication may need to be treated by revascularization. This should not be done too hastily, because any kind of revascularization may be the onset of a vicious cycle of repeated interventions that may accelerate the otherwise benign course of PAD.1 Furthermore, scientific evidence is lacking concerning the efficacy of endovascular therapy on claudication.2 CLI. Patients with CLI represent ⬍5% of those with symptomatic PAD. In younger age groups, CLI is encountered typically in diabetic patients, and a number of ischemic and neuroischemic lesions in diabetic patients do not meet the strict definition of CLI. The risk for amputation at a metatarsal or higher level is eightfold higher in a diabetic patient compared with a nondiabetic patient.3 In addition, type I diabetic patients reach an 86-fold increased risk for any nontraumatic amputation at age ⬍65 years.4 Despite revascularization, ischemic lesions have a slow tendency for healing in diabetics.5 In this patient group, the 5-year survival of patients ⬍65 years old was 60%, while it was 48% in older patients in Helsinki. This is why a durable revascularization should be used to allow wound healing in this young group of patients. In-line arterial flow to the pedal level offers the best results in patients with CLI, as shown by the 10-year data from Pomposelli et al6 with results from 1032 limb salvage bypasses to the dorsalis pedis artery in 865 patients. In this 545

546 Lepäntalo et al

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Fig 1. Leg survival at 1 year after treatment of critical limb ischemia (CLI) using conservative treatment,8-10 spinal cord stimulation,9 venous arterialization,16 percutaneous transluminal angioplasty (PTA),14,15 and bypass.11-13

study, the patency of saphenous vein grafts was better than any other conduit, with a secondary patency rate of 67.6% at 5 years.6 No comparable data are available for endovascular treatment. Results mean everything. Patency is a direct measure of revascularization success when reopening or bypassing occlusions.7 Patency is the key criterion for judging the primary effectiveness of a revascularization but is less often described than leg salvage and amputation-free survival, or even wound healing, quality of life, and sustained ambulation. Patient-related outcomes are, of course, important but strongly affected by other measures than treatment modality itself. Leg survival or leg salvage. Leg salvage or foot preservation, a favored and easy to retrieve end point of CLI studies, is problematic because a number of factors other than revascularization affect the outcome. Leg salvage is an indirect measure of the success of revascularization. The key question is what the leg outcome would be if untreated or treated conservatively. Indeed, in studies reporting outcome of patients with CLI unsuitable for revascularization (CLI verified by ankle pressure ⬍50 mm Hg or toe pressure ⬍30 mm Hg), 1-year leg survival rates of 54%,8 58% for controls with spinal cord stimulation,9 and 66% in patients with an ankle-brachial index ⬍0.5 were reported.10 In this last study, Marston, et al10 reported a wound healing rate of 52% at 1 year. The results of any revascularization should be compared with these data. Four large recent series of bypass surgery for CLI reported leg salvage rates of 88% to 92% at 1 year.6,11–13 The 5-year leg salvage rate of 78% in these four series underlines the durability of bypass surgery.6 Endovascular treatment had 82% to 86% leg salvage rates at 1 year.14,15 Lu et al16 summed up the limited experience available in using distal venous arterialization as the last resort procedure to avoid major amputation, and even that method was associated with 71% leg salvage at 1 year (Fig 1). Mind the gap! We should be careful when considering the so-called patency/leg-salvage gap, which seems wider in

endovascular than in surgical series; that is, occlusion of the revascularized segment leads to amputation less often after an endovascular procedure than after surgical bypass, as summarized by Romiti et al.14 This gap can be explained in different ways. One hypothesis is that leg salvage exceeding the patency of the revascularization procedure is attributable to the early patency, which provides adequate perfusion until ischemic lesions are healed. Thereafter, the leg stays viable if infection is cleared and proper foot care is sustained, especially with diabetic lesions. This concept may, of course, be partly true, but a more obvious explanation is that legs treated by endovascular methods have milder lesions, as illustrated for instance by the impressive results of Faglia et al.17 Leg salvage is actually the improvement achieved by therapeutic measures above natural leg survival (Fig 2). Apples and oranges. Percutaneous transluminal angioplasty (PTA) was recommended for stenosis and bypass for occlusions in the first TransAtlantic Inter-Society Consensus (TASC) document.18 In the second TASC document,19 PTA was still recommended for stenosis and bypass for long occlusions, but there was no consensus on therapy for short and moderate occlusions (Table I). Endovascular therapy for infrapopliteal arterial disease is gaining acceptance as a first-line method to improve ulcer healing and limb salvage, despite lack of evidence. In a recent metaanalysis on infrapopliteal surgery and infrapopliteal endovascular interventions11,14 with 29 and 30 studies included, respectively, 88% of patients were diabetic and 88% had tissue loss among the 2320 in the bypass group, whereas 61% were diabetic and 76% had tissue loss among the 2653 in the endovascular group. No distal pressure measurement was available in this study. Primary and secondary midterm patency rates were better after bypass, but there was no difference in limb salvage. The results of this meta-analysis are biased by the heterogeneity of indications, risk factors, number of treated arterial segments, lesion type (occlusion vs stenosis), lesion length, lesion characteristics, and outflow. In this setting, TASC II classification of femoropop-

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Fig 2. Leg salvage at 1 year after treatment of critical limb ischemia (CLI) with spinal cord stimulation,9 venous arterialization,16 percutaneous transluminal angioplasty (PTA),14,15 and bypass.11-13 The shaded area of the column shows leg salvage attributable to patent revascularization.

Table I. Summary of recommendations of the TransAtlantic Inter-Society Consensus II Working Group22 Segment/recommendation Level of disease

Usually PTA (type A)

PTA preferred (type B)

Surgery preferred (type C)

Femoropopliteal

SFA stenosis ⱕ10 cm or occlusion ⱕ5 cm

Crural

Nonea

SFA stenosis or occlusion ⱕ15 cm; popliteal stenosis Nonea

Outcomes

Excellentb

Excellentb

SFA stenosis or occlusion ⬎15 cm; recurrent disease Stenoses ⱕ4 cm or occlusions ⱕ2 cm PTA/stent only has modest results and is indicated when surgery is contraindicated for technical or patient reasons.

Usually surgery (typeD) Complete SFA or popliteal occlusions Diffuse disease or occlusions ⬎2 cm Endovascular approach is not advised unless symptoms are limb threatening and surgery is not possible.

PTA, Percutaneous transluminal angioplasty; SFA, superficial femoral artery. a Crural interventions have severe outcomes if they go wrong; therefore there is no type A or B recommendation. b Excellent results can be expected from an endovascular approach in all segments.

liteal lesions is not very helpful.20 Furthermore, many studies are flawed for a number of other reasons.21,22 The bypass groups most likely include patients with more severe disease, and only a rather small share of infrainguinal lesions are equally well-treatable with either method (Table I). Data from randomized controlled trials. When endovascular and surgical revascularization are both technically feasible, no significant difference was observed in symptomatic relief in the few randomized controlled trials (RCT) that included both suprainguinal and infrainguinal revascularizations for mixed indications.2 There are two RCTs, including mostly claudicants with superficial femoral artery (SFA) occlusions, which suggest that surgical bypass gives better results than the endovascular approach.23,24 Another RCT25,26 that included a large variety of lesions and mixed indications observed similar outcome after both approaches (Table II). The British Angioplasty vs Surgery in Ischaemic Legs (BASIL) trial is the only large RCT that compared endovascular revascularization and bypass surgery.27 Only patients with CLI or at least severe ischemia and potential candidates for infrainguinal angioplasty or bypass were

included, and 42% of patients were diabetic. Both approaches yielded similar results in amputation-free survival up to 2 years. Surgery was associated with higher postoperative morbidity, more hospital days, and higher costs, and angioplasty was associated with higher need for further revascularization procedures.27 However, the long-term results suggested that surgical repair was more durable,29 but no patency data were available. The results of the BASIL trial emphasize the role of bypass over PTA in fit patients with a saphenous vein available,29 and this was the case in 75% of the patients in BASIL trial. The generalizability of the BASIL trial was audited from a sample of 456 patients with infrainguinal lesions, 236 of whom underwent a revascularization procedure but only 29% were suitable for randomization (ie, treatment by either method). This finding illustrates the narrow overlap of the indications for endovascular and surgical revascularization. The same holds particularly true with the Scandinavian Thrupass vs Bypass Study, in which SFA occlusions were randomized between polytetrafluoroethylene endografting and polytetrafluoroethylene bypass grafting.24 Only 4% of

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Table II. Patency data in randomized controlled studies comparing infrainguinal surgical and endovascular revascularization First author, year

Centers, study period

Van der Zaag,23 13 (1995-1998) 2004

Concealment

No.

Degree of ischemia (Fontaine)

(⫹)

57

II

Adam,27 2005 Bradbury,28 2010

27 (1999-2004)

⫹

452

III-IV

Kedora,25 2007 McQuade,26 2009 Lepäntalo,24 2009

1 private (2004-2005)

–

86 (100 legs)

II-IV

8 (2003-2007)

⫹

44

Lesions treated

Interventions

SFA occlusions 5-15 cm PTA vs bypass (vein 79%) (91%) and stenoses (9%) Infrainguinal lesions PTA first (80% SFA) vs chosen for intervention bypass first (vsm 75%, on the basis of principle infrapopliteal outflow 33%) of equipoise strategies SFA stenoses and PTFE endograft vs bypass occlusions (TASC A-D) (PTFE or polyester)

II (89%); III-IV SFA occlusions 5-25 cm (11%)

PTFE endograft vs bypass (PTFE)

(⫹) Concealment not clearly stated; ARR, absolute risk reduction; CI, confidence interval; HR, hazard ratio; PP, primary patency; PTA, percutaneous transluminal angioplasty; PTFE, polytetrafluoroethylene; SFA, superficial femoral artery; SP, secondary patency; TASC, TransAtlantic Inter-Society Consensus II classification; vsm, vena saphena magna.

the SFA occlusions met the tight inclusion criteria chosen to exclude short occlusions and all lesions with unfavorable landing zones for an endograft. This illustrates the difficult balance between internal and external validity. But when comparable patients are analyzed, bypass seems to give a better result.23,24,29 These data are far less cited than those suggesting noninferiority of endovascular methods (Table II). The findings of the BASIL trial suggest that whether to perform bypass or PTA first for CLI due to infrainguinal disease depends on life expectancy.29 Long-term results favoring bypass were also observed in a large cohort study of 858 CLI patients with a propensity score analysis.30 Complications and costs. Admittedly, bypass surgery is followed by a number of perioperative and late complications. LaMuraglia et al31 recently reported a high incidence of complications related to bypass surgery, according to an American private sector database, with 2.7% mortality and 18.7% major complications, including 7.4% graft thrombosis. In this extended series, complications were associated with age ⬎80 years and poor preoperative functional status.32 Thus, it is difficult to use these data directly to assess the risk of bypass for patients aged ⬍65 years. The complications of PTA are said to be rare and minor and not to preclude a bypass at a later date. Yet, crural interventions may have severe outcomes that cannot be corrected.22 Furthermore, technical failure rates of 20% are associated with attempts to open infrapopliteal occlusions,33 and procedural complication rates of 7% to 17% have been reported.14,15,32 Furthermore, an early death rate of 2.7% in a mixed series indicated that a crural PTAfirst strategy is not without risk.34 Finally, the main predictor of outcome is not the approach used but the patient’s risk profile. According to the BASIL trial,29 surgery was associated with higher number of days in the hospital and the

need for advanced postoperative care. The mean cost of inpatient treatment was one-third higher for a bypassfirst than for a PTA-first strategy, but this was true only during the first year. After 2 years, the cost of repeated new interventions abolished this difference.29 In addition, what the costs of unnecessary interventions are is unclear. Loss of ambulation is also an important cause of increase in costs. Goodney et al12 reported a 81% sustained ambulation rate at 1 year in patients treated by bypass for CLI. The approaches to maximize early detection and optimize therapy for PAD have been emphasized in the literature with the hope to lessen the number of patients with CLI.35 This is absolutely true for risk factors and best medical treatment, but there are no data to show that indications for revascularizations should be extended. Regional data from Southern Finland have shown that endovascular activity for CLI has been doubled during the past 5 years but without any positive effect on major amputation rates. An interesting although biased analysis could be made using the present data to assess the effectiveness of the current practice (Figs 1 and 2). To save one leg for 1 year, three to four legs should be treated by bypass operations and six to seven legs by endovascular interventions. Indeed, scientific evidence is lacking to assess the true efficacy of endovascular therapy on critical ischemia.2 CONCLUSIONS The aim is always to revascularize the leg properly in CLI, with a resulting well-perfused foot to allow ulcer healing. A durable solution can be achieved by bypass using good-quality saphenous vein and by ascertaining good outflow. Bypass surgery and endovascular interventions are complementary techniques for revascularization. If endovascular and bypass procedures were possible with equal outcomes, then endovascular treatments would be pre-

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Table II. Continued. Lost to follow-up

Follow-up

10%

Median 23 months

2%

Outcome and results

Significance

Comment

PP: PTA 43%, bypass 82%

ARR by open surgery 31%

66 months

No difference in amputation-free survival

Unadjusted HR 1.07 (95% CI 0.72-1.6)

12%

Median 18 months

PP: PTA 74%, bypass 74% SP: PTA 84%, bypass 84%

NS NS

14%

Median 24 months

PP: PTA 46%, bypass 84% SP: PTA 63%, bypass 100% (technical endograft failures excluded)

P ⫽ .18 P ⫽ .05

Poor recruitment, early termination High quality and relevance. Results ⬎2 years suggest superiority of bypass 2-year results suggest a trend toward decreased endograft patency with higher TASC classification Poor recruitment, termination due to results of interimanalysis

ferred. However the main issue, especially in younger patients, is the durability of the revascularization: better to trust a bypass with a good vein to an artery with good outflow. Despite early PAD in patients ⬍65 years old, the longevity is not shortened to an extent to allow the second best treatment of choice to be selected. Endovascular techniques and equipment are developing rapidly, but scientific evidence of these new methods is scarce. Level I evidence concerning subintimal angioplasty, drug-eluting balloons, cryoplasty, and the other latest endovascular innovations do not exist. When available, scientific data include mainly short case-series, and because new techniques are introduced all the time, the target is moving too rapidly to collect proper scientific data. REFERENCES 1. Lepäntalo M, Salenius JP, Albäck A, Ylönen K, Luther M. Frequency of repeated vascular surgery. A survey of 7616 surgical and endovascular Finnvasc procedures. Finnvasc Study Group. Eur J Surg 1996; 162:279-85. 2. SBU rapport (The Swedish Council on Technology Assessment in Health Care): Benartärsjukdom–Diagnostik och behandling. Bergqvist D, Delle M, Eckerlund I, Holst J, Jogestrand T, Jörneskog G, et al, editors. Mölnlycke: Elanders Infologistics Väst AB; 2007; no 187. p 1-704. 3. Johannesson A, Larsson GU, Ramstrand N, Turkiewicz A, Wiréhn AB, Atroshi I. Incidence of lower-limb amputation in the diabetic and nondiabetic general population: a 10-year population-based cohort study of initial unilateral and contralateral amputations and reamputations. Diabetes Care 2009;32:275-80. 4. Jonasson JM, Ye W, Sparén P, Apelqvist J, Nyrén O, Brismar K. Risks of nontraumatic lower-extremity amputations in patients with type 1 diabetes: a population-based cohort study in Sweden. Diabetes Care 2008;31:1536-40. 5. Söderström M, Arvela E, Albäck A, Aho PS, Lepäntalo M. Healing of ischaemic tissue lesions after infrainguinal bypass surgery for critical leg ischaemia. Eur J Vasc Endovasc Surg 2008;36:90-5. 6. Pomposelli FB, Kansal N, Hamdan AD, Belfield A, Sheahan M, Campbell DR, et al. A decade of experience with dorsalis pedis artery

7. 8. 9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

Cited in literature 39 474 41 84 28

10

bypass: analysis of outcome in more than 1000 cases. J Vasc Surg 2003;37:307-15. Hertzer NR. Outcome assessment in vascular surgery - results mean everything. J Vasc Surg 1995;21:6-15. Lepäntalo M, Mätzke S. Outcome of unreconstructed chronic critical leg ischaemia. Eur J Vasc Endovasc Surg 1996;11:153-7. Ubbink DT, Vermeulen H. Spinal cord stimulation for critical leg ischemia: a review of effectiveness and optimal patient selection. J Pain Symptom Manage 2006;31:S30-5. Marston WA, Davies SW, Armstrong B, Farber MA, Mendes RC, Fulton JJ, et al. Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg 2006; 44:108-14. Albers M, Romiti M, Brochado-Neto FC, De Luccia N, Pereira CA. Meta-analysis of popliteal-to-distal vein bypass grafts for critical ischemia. J Vasc Surg 2006;43:498-503. Goodney PP, Likosky DS, Cronenwett JL, Vascular Study Group of Northern New England. Predicting ambulation status one year after lower extremity bypass. J Vasc Surg 2009;49:1431-9. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ, et al. Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg 2006;43:742-50. Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 2008;47:975-81. DeRubertis BG, Faries PL, McKinsey JF, Chaer RA, Pierce M, Karwowski J, et al. Shifting paradigms in the treatment of lower extremity vascular disease: a report of 1000 percutaneous interventions. Ann Surg 2007;246:415-22. Lu XW, Idu MM, Ubbink DT, Legemate DA. Meta-analysis of the clinical effectiveness of venous arterialization for salvage of critically ischaemic limbs. Eur J Vasc Endovasc Surg 2006;31:493-9. Faglia E, Dalla Paola L, Clerici G, Clerissi J, Graziani L, Fusaro M, et al. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg 2005;29:620-7. Management of peripheral arterial disease (PAD). TransAtlantic InterSociety Consensus (TASC. Eur J Vasc Endovasc Surg 2000;19(Suppl A):S1-250. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral

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20.

21. 22. 23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

35.

arterial disease (TASC II). Eur J Vasc Endovasc Surg 2007;33(Suppl 1):S1-75. Kukkonen T, Korhonen M, Halmesmäki K, Lehti L, Tiitola M, Aho P, et al. Poor inter-observer agreement on the TASC II classification of femoropopliteal lesions. Eur J Vasc Endovasc Surg 2010;39:220-4. Lepäntalo M. Are results from surgical series equivocal? Ann Chir Gynaecol 1993;82:215-7. Beard JD. Which is the best revascularization for critical limb ischemia: endovascular or open surgery? J Vasc Surg 2008;48(6 Suppl):11S-6S. van der Zaag ES, Legemate DA, Prins MH, Reekers JA, Jacobs MJ. Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial. Eur J Vasc Endovasc Surg 2004;28:132-7. Lepäntalo M, Laurila K, Roth WD, Rossi P, Lavonen J, Mäkinen K, et al. PTFE bypass or thrupass for superficial femoral artery occlusion? A randomised controlled trial. Eur J Vasc Endovasc Surg 2009;37:578-84. Kedora J, Hohmann S, Garrett W, Munschaur C, Theune B, Gable D. Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease. J Vasc Surg 2007;45:10-6. McQuade K, Gable D, Hohman S, Pearl G, Theune B. Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg 2009;49:109-15. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925-34. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. BASIL trial participants. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputationfree and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg 2010;51(5 Suppl):5S-17S. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Multicentre randomised controlled trial of the clinical and costeffectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial. Health Technol Assess 2010;14:1-210. Korhonen M, Biancari F, Söderström M, Arvela E, Halmesmäki K, Albäck A, et al. Femoropopliteal balloon angioplasty vs. bypass surgery for CLI: a propensity score analysis. Eur J Vasc Endovasc Surg 2011; 41:378-84. LaMuraglia GM, Conrad MF, Chung T, Hutter M, Watkins MT, Cambria RP. Significant perioperative morbidity accompanies contemporary infrainguinal bypass surgery: an NSQIP report. J Vasc Surg 2009;50:299-304. Crawford RS, Cambria RP, Abularrage CJ, Conrad MF, Lancaster RT, Watkins MT, et al. Preoperative functional status predicts perioperative outcomes after infrainguinal bypass surgery. J Vasc Surg 2010;51: 351-8. Met R, Van Lienden KP, Koelemay MJ, Bipat S, Legemate DA, Reekers JA. Subintimal angioplasty for peripheral arterial occlusive disease: a systematic review. Cardiovasc Intervent Radiol 2008;31:687-97. Haider SN, Kavanagh EG, Forlee M, Colgan MP, Madhavan P, Moore DJ, et al. Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg 2006;43:504-12. Varu VN, Hogg ME, Kibbe MR. Critical limb ischemia. J Vasc Surg 2010;51:230-41.

PART II: ENDOVASCULAR THERAPY IS THE PREFERRED TREATMENT FOR PATIENTS AGED <65 YEARS OLD WITH SYMPTOMATIC INFRAINGUINAL ARTERIAL DISEASE Rabih Houbballah, MD, Maxime Raux, MD, and Glenn LaMuraglia, MD, Boston, Mass During the last 30 years, the understanding and medical management of peripheral arterial disease (PAD) has

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evolved considerably. Although traditional surgical reconstruction had been the mainstay treatment for failure of medical or local wound therapy, the introduction and development of endovascular procedures has significantly expanded the therapeutic options for treating this patient population. Between 1995 and 2000, catheter-based interventions for infrainguinal disease had increased by nearly 1000%.1 In addition, for the first time, there has been a concurrent decrease in the major amputation rates in “atrisk patients,” although one has to be cautious about linking this outcome improvement to a specific treatment modality or care improvement.2 It is sometimes difficult to assess and compare new modalities of care, such as endovascular procedures, with traditional bypass surgery. This is especially true when considering lower extremity peripheral occlusive disease, where the type of symptomatic presentation, the corresponding anatomic obstructions, the plaque composition, and systemic patient metabolic abnormalities provide a wide spectrum of disease and a very heterogeneous population that makes correlating clinical end points between treatment modalities very challenging. This difficulty is further amplified with recent, rapid improvements of medical therapy for atherosclerotic occlusive disease that have had a varied geographic penetration into this population of patients. Despite these limitations, some comparisons can be made. When analyzing periprocedural outcomes of infrainguinal revascularization during the last decade, endovascular treatment has a significantly lower procedural morbidity and mortality, and hospital length of stay, compared with open bypass surgery.3 With ease of patient tolerance of these procedures and increased familiarity of vascular specialists with its capabilities, endovascular therapy is increasingly considered as the initial treatment of choice for symptomatic patients with PAD, whether the lesions are simple or complex, focal or diffuse, single or multiple, calcified, or noncalcified.4,5 Multiple clinical trials have confirmed that an endovascular-first approach reduces morbidity, mortality, and costs while preserving surgical options for subsequent revascularizations.6 – 8 Opponents of the use of percutaneous transluminal angioplasty (PTA) as the initial treatment emphasize its inferior long-term primary patency compared with vein graft bypass surgery. To maintain a comparable midterm and long-term assisted patency and limb salvage with PTA, patients frequently require secondary procedures more often than after bypass surgery. For this reason, these proponents believe that in young patients with a reasonable long-term life expectancy, bypass surgery should be the first-line treatment. To argue an endovascular first-line strategy, even in patients aged ⬍ 65 years, the following arguments will be proposed: 1. Patients with PAD have a significantly reduced life expectancy, making use of an endovascular approach a timely consideration.

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2. Periprocedural morbidity and mortality are considerably lower with PTA. 3. Secondary interventions after primary endovascular failure are safe, effective, and provide assisted-patency and limb salvation comparable to undertaking first-line bypass surgery. 4. Bypass failure, compared with PTA failure, can be an ominous event for patients with PAD, resulting in poor outcome for limb preservation. 5. Costs between PTA and bypass are comparable. Patients with PAD have a significantly reduced life expectancy, making use of an endovascular approach a timely consideration. Excluding patients with critical limb ischemia (CLI), who have even worse longevity, patients with symptomatic PAD have 5-, 10- and 15-year all-cause mortality rates of 30%, 50%, and 70%, respectively.9 In fact, the mortality rate of patients with claudication is 2.5 times higher than age-matched controls.9 Patients with chronic CLI have a 20% mortality in the first year after presentation, and the recent long-term results of the British Angioplasty vs Surgery in Ischemic Legs (BASIL) trial showed a 56% mortality rate at 4 years,10 while another recent cohort study in this patient population identified a 12% annual death rate.5 Coronary artery disease is by far the most common cause of death among patients with PAD (40%-60%), with cerebral artery disease accounting for 10% to 20% of deaths.9 There are multiple predictive factors of death in PAD patients that can further stratify the individual patient’s risk, including age, presence of tissue loss, serum creatinine, extent of coronary artery disease and cerebrovascular disease, severity of the PAD itself, body mass index, smoking status, pulmonary disease, and congestive heart failure.7,11,12 Therefore, patients with symptomatic PAD have a significantly shortened longevity compared with the general population. Thus, when considering a treatment for symptomatic infrainguinal disease, minimizing periprocedural morbidity and rehabilitation time take on a higher importance, whereas extended durability of the reconstructions, although always a high priority, need to be considered relative to the patient’s life expectancy. Periprocedural morbidity and mortality are considerably lower with PTA. There has been good evidence that the more extensive the vascular procedure the higher the periprocedural morbidity and mortality.13,14 In a large, prospective, contemporary series of 2404 patients (mean age, 67 years) undergoing infrainguinal bypass surgery, the 30-day mortality was 2.7%, with a composite mortality/ major morbidity rate of 19.5%.13 Major complications occurred in 18.7%, which encompassed 9.4% wound infections and 7.4% graft thromboses. A subanalysis of these data for only claudication patients (52%), revealed a lower mortality of 2% and composite major morbidity/mortality of 14.5%. Results were comparable in the prospective, randomized Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT) III trial (mean age, 68

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years) of vein graft bypass in patients with CLI that identified a 30-day mortality of 2.7% with major complications of 17.8%.15 With judicious hydration and limiting iodinated contrast administration, periprocedural morbidity after PTA is unusual and mostly due to groin hematoma, bleeding, and development of a pseudoaneurysm.5 Complication rates of 1% to 5% have been reported in claudication patients16,17 and 2% to 5% in CLI patients.7 A recent large study of PTA in CLI patients (mean age, 70 years) reported a rate of 4% of groin or retroperitoneal hematoma requiring transfusion.5 Mean hospital stay after an infrainguinal PTA is 1 ⫾ 0.02 days, with an immediate return to active life, especially in intermittent claudication patients, whereas length of stay after surgery is 4.52 ⫾ 0.31 days.18 When short-term outcomes of infrainguinal vein bypass are examined, hospital readmissions ⱕ6 months have been reported in 49% of patients, 65% of which were related to problems resulting from the index operation.6 Because there is lower complication rate for PTA, the 30-day hospital readmission rate has been reported to be 6%.19 PAD, and especially CLI, causes a natural reduction of physical function. The ultimate goal in these patients is a functional status and quality of life. A study evaluating diabetic patients at 6 months after undergoing infrainguinal bypass for limb salvage reported that less than half of the patients felt being “back to normal,” and 74% of patients required devices to assist with walking.20 Interestingly, the functional status at follow-up was independent of patient age in this primarily diabetic cohort. Another study focusing on functional outcomes after bypass for CLI identified a 19% loss of ambulation and a 5% loss of independent living.21 A recent meta-analysis examined preoperative and postoperative ambulatory status and independent living in patients undergoing revascularization for CLI. Of the 10 studies that reviewed postoperative bypass outcomes at 6 to 12 months, there was a 12% decline in ambulatory status and a 15% loss of semi-independent living.22 The meta-analysis found only one study that evaluated ambulatory status 12 months after PTA in a cohort of 122 patients, and there was a 6% loss of ambulatory status.22 The BASIL trial also addressed this issue in the short-term and long-term follow-up data, with no significant improvement in quality of life found between the PTA and bypass groups.23 In summary, infrainguinal treatment for symptomatic PAD with PTA offers a lower rate of perioperative morbidity and mortality than bypass for patients with claudication and CLI, resulting in a faster return to normal daily activity. Secondary interventions after primary endovascular failure are safe, effective and provide assisted patency and limb salvage comparable to undertaking first-line bypass surgery. Results of the BASIL randomized study confirmed that endovascular and vein graft bypass treatment of CLI have a similar amputation-free survival and assisted clinical success rates at 2 years.6 Comparison between two meta-analyses of infrageniculate reconstruction for CLI

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found popliteal-to-distal vein bypass grafts24 and infrapopliteal angioplasty25 provided similar outcomes. Both studies used similar methods and targeted the same patient population. At 1 and 6 months, and at 1, 2, and 3 years, primary patency were higher with bypass reconstruction. However, overall limb salvage was comparable in both meta-analyses (82%).24,25 Using PTA to treat the femoral-popliteal segment also provides very respectable outcomes, with primary and assisted patency of 65% and 93%, respectively, at 3 years.17 Infrapopliteal PTA with 40 months average follow-up identified a primary patency of 62%, an assisted patency of 90%, and an overall limb preservation rate of 86%.7 More recently, an evaluation at 5 years of 409 CLI patients treated with PTA as a first-line therapy demonstrated a low primary patency of 31%, an assisted patency that improved to 75%, and an excellent limb salvage rate of 74%.5 The BASIL study is the only randomized study to try to answer the question of superiority of a bypass surgery-first strategy vs a PTA-first strategy in treatment of CLI patients.6 The 5-year results do indicate that in the analysis of only the subgroup of patients who have survived 2 years after randomization (subset of survivors, not all patients), there was a significantly higher overall survival in the bypass-first group but not a significant higher amputationfree survival, even suggesting they may be different patient cohorts.26 There was also a higher early failure rate of PTA-first patients compared with surgery-first patients, and that many of the PTA-first patients ultimately required bypass surgery. Another conclusion was that surgical patients who had undergone prior PTA had worse outcomes than those who only had surgery.10 However, this did not address the specific question of whether a prior PTA later excluded, by loss of anatomic runoff, a subsequent surgical option, but rather that patients who had surgery after failed PTA did not fare as well as those who only had a primary surgery. Indeed, because this is a group of a failed intervention, they may have been more appropriately compared with the group who had surgery after a failed surgical procedure. Although the BASIL trial is Level I evidence data, there are several problems with it that would indicate some caution in the data interpretation. The investigational site audits, including the suitability of randomization, consent, and crossover to the opposite arm of the study, resulted in approximately one in 10 presenting patients actually enrolling in the study arm that they were originally randomized to, thus somewhat preselecting the cohort of patients entered into the study. In addition, the PTA arm of the study was undertaken primarily by radiologists and the surgery arm by the surgeons, which might have introduced differences in the approach and the treatment of these complex patients with multilevel disease.10 A large, prospective, registry-based study of infrapopliteal procedures in CLI highlighted that bypass and surgery achieved similar 5-year rates of leg salvage (75.3% vs 76.0%), survival (47.5% vs 43.3%), and amputation-free survival (37.7% vs 37.3%).27 To reduce confounding fac-

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tors, a propensity score was used to analyze the data, which yielded equivalent results of both PTA-first and bypass-first treatment arms. PTA of the superficial femoral artery has better primary, assisted primary, and secondary patency than prosthetic bypass in the above-knee position.28 Femorodistal bypasses with a prosthetic graft have a very low secondary patency (25% at 5 years) and are known to have loss of outflow during graft failure.29 Therefore, in patients with no available venous conduit or who are at a high risk for bypass, PTA can be considered the preferred initial therapy for TransAtlantic Inter-Society Consensus (TASC) B and C lesions.30 In summary, infrainguinal vein bypass have the highest primary patency rates long-term. However, through close follow-up and secondary interventions, similar limb salvation rates can be achieved with PTA treatment. Midterm and long-term patency are better with PTA compared with prosthetic bypass. Bypass failure, compared with PTA failure, can be an ominous event for patients with PAD, resulting in poor outcome for limb preservation. When performed by an experienced interventionist who understands the limits of the technique and the subsequent surgical options for revascularization, an attempted or failed PTA for infrainguinal arterial disease can be very often safely treated by a new PTA or a surgical bypass. Multiple studies have demonstrated that first-line therapy with PTA/stent does not preclude reintervention with PTA or a secondary surgical revascularization.17,31,32 All studies showed that secondary bypass feasibilities, patency, and limb salvation rates were similar to the primary bypass patency and feasibilities.33,34 The contradiction of these observations in the BASIL study10 was addressed in the previous section. Another study raised the question of a prior PTA resulting in a lower success rate of subsequent bypass.35 There were several limitations in this study. The data were obtained from a database where the anatomic site and the number of PTA prior to bypass were unknown. In addition, the group with a prior PTA was mostly female and required the use of arm vein conduit, two factors associated with inferior longterm patency. Consequences of a failed infrainguinal bypass can be more deleterious.36 Early graft failure (ⱕ1 month of surgery) has been reported in approximately 5% to 10% of patients37,38 and has been correlated with increased limb loss.37 In addition, the long-term secondary patency of a thrombosed vein graft that has undergone thrombectomy or thrombolysis is ⬃36% at 1 year.39 Reoperative bypass surgery for a failed graft also has inferior results. Results of those secondary bypass surgeries are also poor (14% early graft failure with vein graft and 30% with prosthetic grafts, 50% primary patency at 5 years with venous bypass), which is mainly due to severe scarring in the operative field or lack of ipsilateral saphenous vein that necessitates use of alternative poor vein conduits or prosthetic grafts.40,41 In summary, the percutaneous procedure should be always undertaken with consideration of backup surgical

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options should the initial PTA be unsuccessful or fail. Thrombosis of a bypass is a poor prognostic factor, because secondary patency is poor and secondary bypasses have diminished long-term patency. Costs between PTA and bypass are comparable. In the BASIL trial, the periprocedural morbidity of the PTAfirst strategy was significantly lower than the bypass-first strategy. As a consequence, the resource utilization and hospital length of stay were significantly higher in the surgery group. This was responsible for a mean hospital cost one-third higher in the bypass group during the first year.6,42 Owing to a higher rate of reintervention over the duration of the study in the PTA-first cohort, the cost between the two groups equalized by the end of the study.23 Cost analysis also depends on practice patterns, use of stents, and differences in the patient’s clinical presentation. In addition, the equipment expenditure between 2001 and 2007 has seen the average cost for PTA increase ⬎60% for claudication and limb-threatening ischemia, reaching $14,084 and $23,196, respectively.18 From, recent data comparing PTA and surgical treatment in appropriately selected patients, the amortized cost per day of patency is comparable in claudication or chronic limb ischemia patients.8 CONCLUSIONS Although treatment of risk factors for PAD has made significant advances in the last several decades, failure of medical therapy resulting in symptomatic infrainguinal occlusive disease relies on PTA or bypass to improve perfusion. Because patients with PAD have a shorter life expectancy than the general population, the most effective method of revascularization to return patients back to their functional state would be ideal. This would entail symptomatic relief, with minimal morbidity and lesion healing, if present, as the critical end points. In addition to minimal periprocedural morbidity, PTA has a better limb salvage rate and assisted patency than prosthetic bypass and results that approach the gold standard of venous bypass. Nevertheless, because bypass surgery may become a future treatment modality, care should be taken not to undertake PTA options that may obviate those possible future treatments. Even as the present algorithms of medical, interventional, and surgical care for claudication and limb-threatening ischemia remain highly controversial, they have resulted in a 25% decrease the major lower extremity amputation rate within the last 15 years.2 REFERENCES 1. Anderson PL, Gelijns A, Moskowitz A, Arons R, Gupta L, Weinberg A, et al. Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000. J Vasc Surg 2004;39:1200-8. 2. Goodney PP, Beck AW, Nagle J, Welch HG, Zwolak RM. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg 2009;50:54-60. 3. Sadek M, Ellozy SH, Turnbull IC, Lookstein RA, Marin ML, Faries PL. Improved outcomes are associated with multilevel endovascular intervention involving the tibial vessels compared with isolated tibial intervention. J Vasc Surg 2009;49:638-43; discussion 643-34.

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4. Kudo T, Chandra FA, Kwun WH, Haas BT, Ahn SS. Changing pattern of surgical revascularization for critical limb ischemia over 12 years: endovascular vs. open bypass surgery. J Vasc Surg 2006;44:304-13. 5. Conrad MF, Crawford RS, Hackney LA, Paruchuri V, Abularrage CJ, Patel VI, et al. Endovascular management of patients with critical limb ischemia. J Vasc Surg 2011;53:1020-5. 6. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925-34. 7. Conrad MF, Kang J, Cambria RP, Brewster DC, Watkins MT, Kwolek CJ, et al. Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease. J Vasc Surg 2009;50:799-805 e794. 8. Ramay F, Mehta M, Roddy SP. Cost per day of patency: implications of patency and reinterventions following endovascular vs. surgical lower extremity revascularizations. Presented at: 38th Annual Meeting for the New England Society for Vascular Surgery, Providence, RI; 2011. 9. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(Suppl S):S5-67. 10. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial: analysis of amputation free and overall survival by treatment received. J Vasc Surg 2010;51(5 Suppl):18S-31S. 11. van Kuijk JP, Flu WJ, Welten GM, Hoeks SE, Chonchol M, Vidakovic R, et al. Long-term prognosis of patients with peripheral arterial disease with or without polyvascular atherosclerotic disease. Eur Heart J 2010; 31:992-9. 12. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial: A survival prediction model to facilitate clinical decision making. J Vasc Surg 2010;51(5 Suppl):52S-68S. 13. LaMuraglia GM, Conrad MF, Chung T, Hutter M, Watkins MT, Cambria RP. Significant perioperative morbidity accompanies contemporary infrainguinal bypass surgery: an NSQIP report. J Vasc Surg 2009;50:299-304, 304 e291-294. 14. Lancaster RT, Conrad MF, Patel VI, Cambria RP, LaMuraglia GM. Predictors of early graft failure after infrainguinal bypass surgery: a risk-adjusted analysis from the NSQIP. Eur J Vasc Endovasc Surg 2012;43:549-55. 15. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ, et al. Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery. J Vasc Surg 2006;43:742-51; discussion:751. 16. Surowiec SM, Davies MG, Eberly SW, Rhodes JM, Illig KA, Shortell CK, et al. Percutaneous angioplasty and stenting of the superficial femoral artery. J Vasc Surg 2005;41:269-78. 17. Conrad MF, Cambria RP, Stone DH, Brewster DC, Kwolek CJ, Watkins MT, et al. Intermediate results of percutaneous endovascular therapy of femoropopliteal occlusive disease: a contemporary series. J Vasc Surg 2006;44:762-9. 18. Sachs T, Pomposelli F, Hamdan A, Wyers M, Schermerhorn M. Trends in the national outcomes and costs for claudication and limb threatening ischemia: angioplasty vs bypass graft. J Vasc Surg 2011;54:1021-31 e1021. 19. O’Brien-Irr MS, Harris LM, Dosluoglu HH, Dayton M, Dryjski ML. Lower extremity endovascular interventions: can we improve costefficiency? J Vasc Surg 2008;47:982-7; discussion 987. 20. Gibbons GW, Burgess AM, Guadagnoli E, Pomposelli FB, Freeman DV, Campbell DR, et al. Return to well-being and function after infrainguinal revascularization. J Vasc Surg 1995;21:35-44; discussion: 44-35. 21. Chung J, Bartelson BB, Hiatt WR, Peyton BD, McLafferty RB, Hopley CW, et al. Wound healing and functional outcomes after infrainguinal bypass with reversed saphenous vein for critical limb ischemia. J Vasc Surg 2006;43:1183-90. 22. Rollins KE, Coughlin PA. Functional outcomes following revascularisation for critical limb ischaemia. Eur J Vasc Endovasc Surg 2012;43: 420-5. 23. Forbes JF, Adam DJ, Bell J, Fowkes FG, Gillespie I, Raab GM, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial:

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24.

25.

26.

27.

28.

29. 30.

31.

32.

33.

health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis. J Vasc Surg 2010;51(5 Suppl):43-51S. Albers M, Romiti M, Brochado-Neto FC, De Luccia N, Pereira CA. Meta-analysis of popliteal-to-distal vein bypass grafts for critical ischemia. J Vasc Surg 2006;43:498-503. Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 2008;47:975-81. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplastyfirst revascularization strategy. J Vasc Surg 2010;51(5 Suppl):5S-17S. Söderström MI, Arvela EM, Korhonen M, Halmesmäki KH, Albäck AN, Biancari F, et al. Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery as first-line strategies in critical leg ischemia: a propensity score analysis. Ann Surg 2010;252:765-73. Dosluoglu HH, Cherr GS, Lall P, Harris LM, Dryjski ML. Stenting vs above knee polytetrafluoroethylene bypass for TransAtlantic Inter-Society Consensus-II C and D superficial femoral artery disease. J Vasc Surg 2008;48:1166-74. Beard JD. Which is the best revascularization for critical limb ischemia: endovascular or open surgery? J Vasc Surg 2008;48(6 Suppl):11S-6S. Nolan B, Finlayson S, Tosteson A, Powell R, Cronenwett J. The treatment of disabling intermittent claudication in patients with superficial femoral artery occlusive disease--decision analysis. J Vasc Surg 2007;45:1179-84. Molloy KJ, Nasim A, London NJ, Naylor AR, Bell PR, Fishwick G, et al. Percutaneous transluminal angioplasty in the treatment of critical limb ischemia. J Endovasc Ther 2003;10:298-303. Hynes N, Akhtar Y, Manning B, Aremu M, Oiakhinan K, Courtney D, et al. Subintimal angioplasty as a primary modality in the management of critical limb ischemia: comparison to bypass grafting for aortoiliac and femoropopliteal occlusive disease. J Endovasc Ther 2004;11:460-71. Joels CS, York JW, Kalbaugh CA, Cull DL, Langan EM, Taylor SM. Surgical implications of early failed endovascular intervention of the superficial femoral artery. J Vasc Surg 2008;47:562-5.

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34. Sandford RM, Bown MJ, Sayers RD, London JN, Naylor AR, McCarthy MJ. Is infrainguinal bypass grafting successful following failed angioplasty? Eur J Vasc Endovasc Surg 2007;34:29-34. 35. Nolan BW, De Martino RR, Stone DH, Schanzer A, Goodney PP, Walsh DW, et al. Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor outcome after lower extremity bypass. J Vasc Surg 2011;54:730-5; discussion:735-6. 36. Thompson MM, Sayers RD, Reid A, Underwood MJ, Bell PR. Quality of life following infragenicular bypass and lower limb amputation. Eur J Vasc Endovasc Surg 1995;9:310-3. 37. Belkin M. Secondary bypass after infrainguinal bypass graft failure. Semin Vasc Surg 2009;22:234-9. 38. Abbruzzese TA, Havens J, Belkin M, Donaldson MC, Whittemore AD, Liao JK, et al. Statin therapy is associated with improved patency of autogenous infrainguinal bypass grafts. J Vasc Surg 2004;39: 1178-85. 39. Belkin M, Donaldson MC, Whittemore AD, Polak JF, Grassi CJ, Harrington DP, et al. Observations on the use of thrombolytic agents for thrombotic occlusion of infrainguinal vein grafts. J Vasc Surg 1990;11:289-94; discussion 295-6. 40. Belkin M, Conte MS, Donaldson MC, Mannick JA, Whittemore AD. Preferred strategies for secondary infrainguinal bypass: lessons learned from 300 consecutive reoperations. J Vasc Surg 1995;21:282-93; discussion 293-5. 41. Edwards JE, Taylor LM, Jr, Porter JM. Treatment of failed lower extremity bypass grafts with new autogenous vein bypass grafting. J Vasc Surg 1990;11:136-44; discussion 144-5. 42. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Multicentre randomised controlled trial of the clinical and costeffectiveness of a bypass-surgery-first versus a balloon-angioplastyfirst revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial. Health Technol Assess 2010;14:1210, iii-iv.

EDITORS’ COMMENTARY

Thomas L. Forbes, MD, and Jean-Baptiste Ricco, MD, PhD, London, Ontario, Canada; and Poitiers, France Our debaters have argued their preferred approaches for younger patients with symptomatic peripheral arterial disease (PAD) and have included such issues as procedure-related morbidity, patency and durability, reinterventions, and life expectancy. A similar discussion could occur regarding younger patients with abdominal aortic aneurysms and the comparative value of an endovascular or open repair. However, this analogy is not entirely appropriate. Whereas durability of the repair and need for reintervention is especially relevant in these young aneurysm patients with their longer life expectancies, young PAD patients represent a group with more aggressive systemic atherosclerotic disease. At best, these younger patients can expect an absolute life expectancy similar to their older symptomatic PAD counterparts.1 The early presentation of symptomatic PAD is a marker of coinciding premature atherosclerotic disease in the coronary and carotid circulations. Medical therapy and risk factor modification are especially vital in these patients, regardless of the operative or interventional approach used for their PAD. Specific risk factors, including lipoprotein(a) level ⬎30 mg/dL, have been identified as risk factors for premature PAD, especially in men.2 Despite adequate medical therapy and diabetes management, these patients are at increased risk for major cardiovascular events. Recent evidence would suggest that young women with PAD are especially susceptible to cardiovascular events compared with men, whereas risks are more similar in older age groups.3

Along with a more aggressive form of systemic atherosclerotic disease, young PAD patients appear to be predisposed to multiple procedures or interventions. A review of younger men with symptomatic PAD found 40% required multiple interventions because of progression of their disease or bypass graft failure.1 Predictors of treatment failure have been investigated recently. In a cohort of Chinese patients, 38% of young PAD patients had thrombophilia that proved to be an independent predictor of graft thrombosis and major amputation at 30 days and of decreased patency and limb salvage after 1 year.4 Young patients with symptomatic PAD represent an especially challenging group for vascular surgeons. As with older patients, they represent a population with aggressive systemic atherosclerosis and a somewhat limited life expectancy. Aggressive medical therapy and risk factor modification are mandatory, and the choice of bypass or endovascular therapy for their PAD needs to reflect this limited life expectancy. In PAD patients of all ages in the Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL) trial,5 bypass with adequate great saphenous vein was superior to angioplasty in those with a life expectancy ⬎2 years. Regardless, the optimal therapy should limit periprocedural morbidity and mortality, should be durable, require few—if any— reinterventions, and be successful in resolving symptoms and avoiding major amputation. These are complex decisions and should be individualized to the patient’s symptoms, anatomy, and comorbidi-